We offer cross-industry experience combined with advocacy in product registration in Russia and ex-USSR countries.
Russian Pharmalicensing Group can help in all areas of regulatory affairs relating to many different products.
- Regulatory planning
- Advice on regulatory requirements
- Scientific writing and reviewing dossier
- Troubleshooting an unsuccessful submission or conducting an appeal
- Liaison with the regulatory authorities
- Post-marketing Maintenance
- Pharmacovigilance incl. Safety reporting, PSURs
- Clinical trials: design, initiation and management of phase III and IV clinical trials
- Biosimilar Clinical Trials
- Regulatory Affairs Labeling